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A Randomized, Controlled, Double-Blind Study Comparing the Survival Benefit of Four Different Reverse Transcriptase Inhibitor Therapies (Three-Drug, Two-Drug, and Alternating Drug) for the Treatment of Advanced AIDS.

Objective: The primary objective was to compare the effects of dual or triple combinations of HIV-1 reverse transcriptase inhibitors with respect to survival. The time to new HIV disease progression or death, toxicities, the change in CD4 cells, and plasma HIV-1 RNA concentrations in a subset of study subjects were evaluated.

Design: This was a multicenter randomized, double-blind, placebo-controlled study.

Setting: The study was conducted among 42 adult AIDS Clinical Trials Group sites and 7 National Hemophilia Foundation centers.

Patients: 1313 HIV-infected patients with CD4 counts <=50 cells/mm3 participated in this study, which was conducted from June 1993 to June 1996.

Main Outcome Measures: The main outcome was survival (i.e., time to death).

Results: A significant difference in survival time was found between the four treatment groups, favoring those assigned to triple therapy (p = .02). A significant difference was also found in the delay of disease progression or death among the four treatment arms favoring the group assigned to triple therapy (p = .002). Baseline CD4 cell counts and plasma HIV-1 RNA concentrations as well as changes of CD4 counts at week 8 predicted survival for subjects in the virology substudy.

Conclusions: In the pre-protease inhibitor era, a combination of triple reverse transcriptase inhibitors prolonged life and delayed disease progression in AIDS patients with advanced immune suppression.